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Study identifier: NCT05997602 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH

Condition: Langerhans Cell Histiocytosis · LCH  ·  Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

PhasePhase 2
Planned participants56
Who can joinAll sexes, 2 Years to 16 Years
Healthy volunteersNo

About this study

This is a rare disease, single-arm, open-label,multi-center, non-randomized Phase 2 clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of FCN-159 monotherapy in pediatric patients with refractory/recurrent Langerhans cell histiocytosis (LCH).

This description comes directly from the study's public registry record.

Talk to the study team

Rui Zhang, MD  ·  18611106187  ·  ruizh1973@126.com

Always discuss trial participation with your own doctor first.

Locations (11)

Beijing Children's Hospital, Capital Medical UniversityBeijing, Beijing Municipality, ChinaRecruiting
Children's Hospital Affiliated to the Capital Institute of PediatricsBeijing, Beijing Municipality, ChinaNot Yet Recruiting
Children's Hospital of Chongqing Medical UniversityChongqing, Chongqing Municipality, ChinaRecruiting
Sun Yat-Sen Memorial Hpsipital,Sun Yat-Sen UnniversityGuangzhou, Guangdong, ChinaNot Yet Recruiting
The First Affiliated Hospital,Sun Yat-sen UniversityGuangzhou, Guangdong, ChinaNot Yet Recruiting
Shenzhen Children's HospitalShenzhen, Guangdong, ChinaNot Yet Recruiting
Henan Children's Hospital Zhengzhou Children's HospitalZhengzhou, Henan, ChinaNot Yet Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and TechnologyWuhan, Hubei, ChinaNot Yet Recruiting
West China Second University Hospital,Sihuan University/West China women's and Children's HospitalChengdu, Sichuan, ChinaNot Yet Recruiting
Children's Hospital, Zhejiang University School of MedicineHangzhou, Zhejiang, ChinaNot Yet Recruiting
Children's Hospital of Soochow UniversitySuzhou, ChinaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT05997602